Phase 4
N=79
Study of Behavioral Weight Loss Therapy for Obesity and Binge Eating in Monolingual Hispanic Persons
Obesity · Binge Eating
Bottom Line
View on ClinicalTrials.gov: NCT00516919 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Participant BMI — 36.0; 36.4; 36.3; 36.8 kg/m^2 — p==0.51
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Xenical + behavioral intervention (Drug); Behavioral intervention + placebo (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant BMI |
36.0; 36.4; 36.3; 36.8 | =0.51 |
Summary
This is a research study designed to examine the effectiveness of an obesity medication (orlistat) given in addition to behavioral weight loss therapy. Participants will be obese monolingual (Spanish-speaking only) men and women.
Eligibility Criteria
Inclusion Criteria
- Monolingual Spanish Speaking
- Obese (BMI >= 30)
Exclusion Criteria
- Pregnancy
- Current cardiac disease
- Serious neurologic illnesses
Data sourced from ClinicalTrials.gov (NCT00516919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.